Acne vulgaris, or acne, is one of the most prevalent diseases worldwide, with skin conditions being one of the top causes of years lived with disability and non-fatal disease burden. Despite being one of the most prevalent diseases worldwide, the most widely used treatments in acne have changed little in the past 30 years. To date there is still no effective treatment that can prevent and cure this disease. The currently available acne therapies have been discovered several decades ago, and almost no progress was made in developments of novel, breakthrough treatment approaches. The present randomized, placebo-controlled, dose escalation, Phase 1 trial (ORI-101-PAC) is intended to investigate the safety, tolerability and immunogenicity of an acne vulgaris vaccine (ORI-A-ce001) at three different dose levels in subjects aged ≥18 years suffering from moderate facial acne vulgaris who are otherwise healthy. The present study will also generate preliminary data on efficacy (inflammatory and non-inflammatory acne lesion counts, acne severity), immunogenicity and functionality of the vaccine, as well as a possible impact on skin microbiome composition. Control groups receiving placebo are included. Data from this trial will be used to inform the design of future studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
38
C. acnes vaccine Injection, 25 mcg, 75 mcg, 225 mcg, 4 single i.m. injections given in monthly intervals
Injection, sterile aqueous solution of aluminium hydroxide, 4 single i.m. injections given in monthly intervals
Universitäts-Hautklinik Tübingen
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Fachklinik Bad Bentheim
Bad Bentheim, North Rhine-Westphalia, Germany
Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB)
Bochum, North Rhine-Westphalia, Germany
CentroDerm
Wuppertal, North Rhine-Westphalia, Germany
UKSH, Campus Lübeck
Lübeck, Schleswig-Holstein, Germany
Incidence of solicited and unsolicited local and/or systemic adverse events (AEs)
Number of participants with AEs as assessed by electronic diary (eDiary) and/or PI assessment, and compared to placebo
Time frame: 7 days following each vaccination
Incidence of AEs and serious adverse events (SAEs)
Incidence of AEs and SAEs
Time frame: Through study completion, an average of 9 months
Number of participants with AEs or SAEs as assessed by physical examination
Number of participants with AEs or SAEs as assessed by physical examination, vital signs, local skin responses, as assessed by treatment arm (vaccine and placebo)
Time frame: Through study completion, an average of 9 months
Change from the baseline in laboratory data
Clinically significant change from the baseline in laboratory data as compared to placebo
Time frame: Through study completion, an average of 9 months
Change from the baseline in vital signs
Clinically significant change from the baseline in vital signs as compared to placebo
Time frame: Through study completion, an average of 9 months
Change from the baseline in ECG
Clinically significant change from the baseline in electrocardiogram (ECG) as compared to placebo
Time frame: Weeks 0 and 36
Change from the baseline in physical examination
Clinically significant change from the baseline in physical examination, as compared to placebo
Time frame: Through study completion, an average of 9 months
Immunogenicity assessment
The amount of vaccine-antigen-specific serum antibody titers (IgG), measured by ELISA, compared to placebo and compared among different treatment groups
Time frame: Weeks 0, 4, 8, 12, 16, 24 and 36
Change in inflammatory lesion counts
Absolute and percentage change from Baseline in the number of inflammatory acne lesions
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Change in non-inflammatory lesion counts
Absolute and percentage change from Baseline in the number of non-inflammatory acne lesions
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Investigator's global assessment (IGA) - change from Baseline
Absolute change in IGA score from Baseline \[scores: 0-4; 0=clear, 4=severe\]
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Investigator's global assessment (IGA) - percentage of subjects with improvement
Percentage of subjects with at least one-grade improvement in their Baseline IGA score (assessment of mild, clear or almost clear) \[scores: 0-4; 0=clear, 4=severe\]
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Assessment of subjects' treatment acceptability
Treatment acceptability, as assessed by the pre-defined questionnaire
Time frame: Week 16
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